Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00466999
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):
Gynuity Health Projects

Tracking Information
First Submitted Date  ICMJE April 25, 2007
First Posted Date  ICMJE April 27, 2007
Last Update Posted Date March 30, 2012
Study Start Date  ICMJE February 2007
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
Complete abortion without recourse to surgical intervention. [ Time Frame: follow up visit 7 days after initial treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 25, 2007)
Complete abortion without recourse to surgical intervention.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Official Title  ICMJE Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Brief Summary In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Incomplete Abortion
Intervention  ICMJE
  • Drug: misoprostol
    single dose of 400 mcg misoprostol administered sublingually
  • Procedure: surgery
    standard surgical treatment (dilation and curettage or manual vacuum aspiration)
Study Arms  ICMJE
  • Active Comparator: surgery
    standard surgical treatment (either dilation and curettage or manual vacuum aspiration)
    Intervention: Procedure: surgery
  • Active Comparator: misoprostol
    400 mcg misoprostol
    Intervention: Drug: misoprostol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2007)
1000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Uterine size no larger than 12 weeks LMP at time of presentation for care.
  • Past or present history of vaginal bleeding during pregnancy.
  • Open cervical os.
  • If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
  • All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
  • General good health.
  • Willing to provide contact information for purposes of follow-up.
  • Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).

Exclusion Criteria:

  • Contraindications to study drug
  • Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
  • Hemodynamic disturbances (pulse >110/min and systolic bp <100)
  • Have an IUD in place; (the IUD may be removed making the woman eligible)
  • Suspected ectopic pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Burkina Faso,   Egypt,   Mauritania,   Niger,   Senegal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00466999
Other Study ID Numbers  ICMJE 2.2.2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynuity Health Projects
Study Sponsor  ICMJE Gynuity Health Projects
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Study Director: Rasha Dabash, MPH Gynuity Health Projects
Study Director: Ayisha Diop, MPH Gynuity Health Projects
PRS Account Gynuity Health Projects
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP